Not currently registered with FDA under this name
Proimtech Saglik Urunleri Anonim Sirketi
Istanbul, Türkiye. Named as applicant on 3 dental 510(k) clearances between 2024 and 2025. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32024–2025
- Markets registered in
- 214 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Proimtech Saglik Urunleri Anonim Sirketi as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Proimtech Saglik Urunleri Anonim Sirketi | 3 clearances | 2024–2025 | Below |
| European Union | EUDAMED | Manufacturer | PROİMTECH SAĞLIK ÜRÜNLERİ ANONİM ŞİRKETİ | 14 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Proimtech Saglik Urunleri Anonim Sirketi as the applicant.
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.